Regulatory Affairs Officer (Medical Device)

About the Job

Join Excelya as a Regulatory Affairs Officer specializing in Medical Devices, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Regulatory Affairs. You will play a critical part in driving innovation and making an impact in the medical device sector, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

• Manage regulatory submissions for medical devices in accordance with U.S. FDA and EU MDR/IVDR requirements.
• Review and assess technical documentation for compliance with regulations, including risk assessments and clinical evaluations.
• Prepare and maintain regulatory files and submissions, ensuring accuracy and completeness.
• Collaborate with cross-functional teams to ensure timely product launches and compliance with post-market surveillance activities.
• Stay updated on regulatory changes and advise the organization on potential impacts on products and processes.

About You:

We are looking for a dedicated and knowledgeable professional with strong expertise in regulatory affairs for medical devices.

• Experience: Minimum of 3-5 years in regulatory affairs, specifically related to medical devices. Proven experience with regulatory submissions
• Skills: In-depth understanding of EU and U.S. medical device regulations, excellent analytical and communication skills, and strong attention to detail.
• Education: Degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
• Languages: Fluency in English and French is required; additional languages are a plus.

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.